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Clinical Trials/NCT04497194
NCT04497194
Completed
Not Applicable

Registry of Biological Samples, Clinical Information and Epidemiological Data of COVID-19 Patients Admitted at the University Hospital of Verona (AOUI Verona)

Azienda Ospedaliera Universitaria Integrata Verona1 site in 1 country430 target enrollmentMarch 1, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Coronavirus Disease 2019
Sponsor
Azienda Ospedaliera Universitaria Integrata Verona
Enrollment
430
Locations
1
Primary Endpoint
Arterial blood gas anaysis pH in COVID-19 patients admitted to University Hospital of Verona
Status
Completed
Last Updated
4 years ago

Overview

Brief Summary

The registry of COVID-19 patients was designed to collect epidemiolgical, demographic, clinical, anamnestic and outcome information together with serological and microbiological samples from COVID-19 patients admitted at the University Hospital of Verona (Azienda Ospedaliera Universitaria Integrata, AOUI Verona). All SARS-CoV 2 positive patients admitted and able to give an informed consent are included, irrespectively of age and gender.

Detailed Description

Anamnestic data are collected at the enrollment, while all the other clinical and epidemiological information are retrieved retrospectively from patients' medical records and electronic health records. Serological and microbiological samples (blood samples, fecal samples and nasal/rectal swabs) are collected within 48 hours after admission and during the hospital stay, according with routine internal procedures.The biological samples are stored at the University Laboratory for Medical Research (Laboratorio Universitario di Ricerca Medica, LURM). A dedicated database has been created and implemented to collect all the above mentioned information.

Registry
clinicaltrials.gov
Start Date
March 1, 2020
End Date
September 30, 2020
Last Updated
4 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Evelina Tacconelli

Professor

Azienda Ospedaliera Universitaria Integrata Verona

Eligibility Criteria

Inclusion Criteria

  • PCR for SARS-CoV 2 positive on NPS swab or high suspicion of SARS-CoV 2 with ongoing swab;
  • All ages;
  • All genders;
  • Informed consent obtained.

Exclusion Criteria

  • Failure to obtain the informed consent.

Outcomes

Primary Outcomes

Arterial blood gas anaysis pH in COVID-19 patients admitted to University Hospital of Verona

Time Frame: through study completion, an average of 3 months

pH

Blood pressure (mmHg) on admission in COVID-19 patients admitted to University Hospital of Verona

Time Frame: through study completion, an average of 3 months

Blood pressure (mmHg)

Respiratory rate (breaths per minute) on admission in COVID-19 patients admitted to University Hospital of Verona

Time Frame: through study completion, an average of 3 months

Pulse rate (beats per minute)

Peripheral oxygen saturation (%) on admission in COVID-19 patients admitted to University Hospital of Verona

Time Frame: through study completion, an average of 3 months

Peripheral oxygen saturation (%)

Body temperature (°C) on admission in COVID-19 patients admitted to University Hospital of Verona

Time Frame: through study completion, an average of 3 months

Body temperature (°C)

Lymphocytes (cell/mm3) in COVID-19 patients admitted to University Hospital of Verona

Time Frame: through study completion, an average of 3 months

Lymphocytes (cell/mm3)

L-lattato deidrogenasi (LDH, mU/ml) in COVID-19 patients admitted to University Hospital of Verona

Time Frame: through study completion, an average of 3 months

LDH (mU/ml)

Creatine kinase (CK, U/L) in COVID-19 patients admitted to University Hospital of Verona

Time Frame: through study completion, an average of 3 months

CK (U/L)

Epidemiological predictors of poor outcomes in COVID-19 patients admitted to University Hospital of Verona

Time Frame: through study completion, an average of 3 months

Epidemiological data including demographic data, contact with COVD-19 positive patients and onset of symptoms.

C reactive protein (CRP, m/gL) in COVID-19 patients admitted to University Hospital of Verona

Time Frame: through study completion, an average of 3 months

CRP (m/gL)

Clinical predictors of poor outcomes in COVID-19 patients admitted to University Hospital of Verona

Time Frame: through study completion, an average of 3 months

Underlying chronic diseases, signs/symptoms related with COVID-19 diseases an clinical presentation on admission

Pulse rate (beats per minute) on admission in COVID-19 patients admitted to University Hospital of Verona

Time Frame: through study completion, an average of 3 months

Pulse rate (beats per minute)

Platelets (cell/mm3) in COVID-19 patients admitted to University Hospital of Verona

Time Frame: through study completion, an average of 3 months

Platelets (cell/mm3)

D-dimer (μg/L) in COVID-19 patients admitted to University Hospital of Verona

Time Frame: through study completion, an average of 3 months

D-dimer (μg/L)

ferritin (mcg/L) in COVID-19 patients admitted to University Hospital of Verona

Time Frame: through study completion, an average of 3 months

ferritin (mcg/L)

Creatinine (mg/dl) in COVID-19 patients admitted to University Hospital of Verona

Time Frame: through study completion, an average of 3 months

Creatinine (mg/dl)

Procalcitonin (PCT, ng/mL) in COVID-19 patients admitted to University Hospital of Verona

Time Frame: through study completion, an average of 3 months

PCT (ng/mL

Neutrophils (cell/mm3) in COVID-19 patients admitted to University Hospital of Verona

Time Frame: through study completion, an average of 3 months

Neutrophils (cell/mm3)

AST (U/L) in COVID-19 patients admitted to University Hospital of Verona

Time Frame: through study completion, an average of 3 months

AST (U/L)

Arterial blood gas anaysis HCO3 (mmol/l) in COVID-19 patients admitted to University Hospital of Verona

Time Frame: through study completion, an average of 3 months

HCO3 (mmol/l)

White Blood Count (WBC, cell/mm3) in COVID-19 patients admitted to University Hospital of Verona

Time Frame: through study completion, an average of 3 months

White Blood Count (WBC, cell/mm3)

fibrinogen (g/L) in COVID-19 patients admitted to University Hospital of Verona

Time Frame: through study completion, an average of 3 months

fibrinogen (g/L)

ALT (U/L) in COVID-19 patients admitted to University Hospital of Verona

Time Frame: through study completion, an average of 3 months

ALT (U/L)

Arterial blood gas anaysis pO2 (mmHg) in COVID-19 patients admitted to University Hospital of Verona

Time Frame: through study completion, an average of 3 months

pO2 (mmHg)

Virological factors associated with the pathogenesis of COVID-19

Time Frame: through study completion, an average of 3 months

Nasal and rectal swabs, fecal samples and blood samples

Arterial blood gas anaysis pCO2 (mmHg) in COVID-19 patients admitted to University Hospital of Verona

Time Frame: through study completion, an average of 3 months

pCO2 (mmHg)

Arterial blood gas anaysis SpO2 (%) in COVID-19 patients admitted to University Hospital of Verona

Time Frame: through study completion, an average of 3 months

SpO2 (%)

Host-related factors associated with the pathogenesis of COVID-19

Time Frame: through study completion, an average of 3 months

IL-6 (pg/mL)

Study Sites (1)

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